Safety and efficacy of dynamic graciloplasty for fecal incontinence - Report of a prospective, multicenter trial

PURPOSE: Dynamic graciloplasty has been used for intractable fecal incontin ence, and good results have been reported. The aim of this study was to ass ess prospectively the safety and efficacy of dynamic graciloplasty for intr actable fecal incontinence in a prospective, multicenter trial. METHODS: A total of 123 adults were treated with dynamic graciloplasty at 2 0 institutions. Continence was assessed preoperatively and postoperatively by use of 14-day diaries. RESULTS: There was one treatment-related death. One hundred eighty-nine adv erse events occurred in 91 patients (74 percent). Forty-nine patients (40 p ercent) required one or more operations to treat complications. One hundred seventy (90 percent) events were resolved. Sixty-three percent of patients without pre-existing stomas recorded a 50 percent or greater decrease in i ncontinent events 12 months after dynamic graciloplasty, and an additional 11 percent experienced lesser degrees of improvement. Twenty-six percent we re not improved, worsened, or exited. In patients with pre-existing stomas, 33 percent achieved successful outcomes at 12 months. This number increase d to 60 percent at 18 months. Seventy-eight percent of patients had increas ed enema retention time, and mean anal canal pressures improved significant ly at 12 months. Significant changes in quality of life were also observed. CONCLUSIONS: Objective improvement can be demonstrated in the majority of p atients with end-stage fecal incontinence treated with dynamic graciloplast y. Reduction in incontinence episodes can be correlated with improved quali ty of life. Adverse events are frequently encountered, but most resolve wit h treatment.